Product code MPN
- Device name
- Tissue Adhesive For The Topical Approximation Of Skin
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4010
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P050013 | HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE | Tissue Seal, LLC | 2007-02-16 |
| P960052S012 | DERMABOND TOPICAL SKIN ADHESIVE | Closure Medical Corp. | 2006-09-14 |
| P960052S011 | HIGH VISCOSITY DERMABOND MINI APPLICATOR | Closure Medical Corp. | 2006-02-10 |
| P960052S010 | HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE | Closure Medical Corp. | 2005-03-21 |
| P960052S009 | DERMABOND TOPICAL SKIN ADHESIVE | Closure Medical Corp. | 2004-09-24 |
| P960052S007 | DERMABOND TOPICAL SKIN ADHESIVE | Closure Medical Corp. | 2003-12-01 |
| P010002S004 | INDERMIL TISSUE ADHESIVE | Covidien Lp, Formerly Registered AS United States | 2003-11-12 |
| P960052S006 | DERMABOND TOPICAL SKIN ADHESIVE | Closure Medical Corp. | 2003-06-13 |
| P010002S003 | INDERMIL TISSUE ADHESIVE | Covidien Lp, Formerly Registered AS United States | 2003-01-31 |
| P960052S004 | DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY | Closure Medical Corp. | 2002-12-31 |
| P960052S005 | DERMABOND TOPICAL SKIN ADHESIVE | Closure Medical Corp. | 2002-07-24 |
| P010002S002 | INDERMIL TISSUE ADHESIVE | Covidien Lp, Formerly Registered AS United States | 2002-06-28 |
| P010002S001 | INDERMIL TISSUE ADHESIVE | Covidien Lp, Formerly Registered AS United States | 2002-06-20 |
| P010002 | INDERMIL(TM) TISSUE ADHESIVE | Covidien Lp, Formerly Registered AS United States | 2002-05-22 |
| P960052S003 | DERMABOND(R) TOPICAL SKIN ADHESIVE | Closure Medical Corp. | 2001-11-19 |
| P960052S002 | DERMABOND TOPICAL SKIN ADHESIVE (2-OCTYL CYANOACRYLATE) | Closure Medical Corp. | 2001-04-04 |
| P960052S001 | DERMABOND TOPICAL SKIN ADHESIVE | Closure Medical Corp. | 2001-02-15 |
| P960052 | DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE) | Closure Medical Corp. | 1998-08-26 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243990 | BondEase 2 Topical Skin Adhesive | Optmed, Inc. | 2025-09-19 |
| K250950 | CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) | Okapi Medical, LLC Dba Resivant Medical | 2025-08-04 |
| K234114 | CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) | Okapi Medical, LLC Dba Resivant Medical | 2024-08-20 |
| K233458 | CM005 Standard (CM005); CM004 Mini (CM004) | Connexicon Medical , Ltd. | 2024-07-15 |
| K230981 | Meriglu Topical Skin Adhesive | M/s. Meril Endo Surgery Private Limited. | 2024-03-16 |
| K212246 | Exofin Precision Pen | Chemence Medical, Inc. | 2021-09-09 |
| K200264 | Exofin High Viscosity Topical Skin Adhesive | Chemence Medical, Inc. | 2020-12-17 |
| K183570 | LiquiBand Plus | Advanced Medical Solutions Limited | 2020-03-09 |
| K162352 | derma+flex QS High Viscosity Tissue Adhesive | Chemence Medical, Inc. | 2016-12-22 |
| K161011 | SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive | Adhezion Biomedical, LLC | 2016-11-08 |
| K161050 | ACTABOND Topical Skin Adhesive | Bergen Medical Products, Inc. | 2016-10-04 |
| K152476 | Exofin High Viscosity Tissue Adhesive | Chemence Medical Products, Inc. | 2016-02-09 |
| K150032 | GluStitch Twist Tissue Adhesive | Glustitch, Inc. | 2016-01-14 |
| K141157 | BONDEASE TOPICAL SKIN ADHESIVE | Optmed, Inc. | 2015-12-22 |
| K151182 | LiquiBand Exceed | Advanced Medical Solutions (Plymouth), Ltd. | 2015-10-26 |
| K152096 | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive | ETHICON, Inc. | 2015-10-22 |
| K150866 | SURGISEAL Topical Skin Adhesvie | Adhezion Biomedical, LLC | 2015-07-17 |
| K133963 | SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE | Adhezion Biomedical, LLC | 2014-09-09 |
| K141215 | SURGISEAL TWIST TOPICAL SKIN ADHESIVE | Adhezion Biomedical, LLC | 2014-08-21 |
| K140343 | AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP | Aesculap, Inc. | 2014-05-13 |
| K140517 | SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE | Adhezion Biomedical, LLC | 2014-04-28 |
| K132243 | BARLE TISSUE ADHESIVE 2 | Advanced Medical Solutions (Plymouth), Ltd. | 2013-12-20 |
| K130329 | SURGISEAL TOPICAL SKIN ADHESIVE | Adhezion Biomedical, LLC | 2013-12-03 |
| K130474 | SURGISEAL TOPICAL SKIN ADHESIVE | Adhezion Biomedical, LLC | 2013-05-31 |
| K123133 | BARLE TISSUE ADHESIVE | Advanced Medical Solutions (Plymouth), Ltd. | 2013-05-22 |
| K121976 | AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE | Aesculap, Inc. | 2013-05-17 |
| K123936 | SURGISEAL TOPICAL SKIN ADHESIVE | Adhezion Biomedical, LLC | 2013-04-24 |
| K122446 | LIQUIDBAND FLOW CONTROL | Advanced Medical Solutions (Plymouth), Ltd. | 2012-10-26 |
| K111959 | AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE | Aesculap, Inc. | 2012-02-06 |
| K110184 | LIQUIBAND FLOW CONTROL | Medlogic Global Limited | 2011-12-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08904255228672 | MERIGLUETM – Topical Skin Adhesive | MERIL ENDO SURGERY PRIVATE LIMITED | 2026-04-18 |
| 08904255228689 | MERIGLUETM – Topical Skin Adhesive | MERIL ENDO SURGERY PRIVATE LIMITED | 2026-04-18 |
| 08904255228665 | MERIGLUETM – Topical Skin Adhesive | MERIL ENDO SURGERY PRIVATE LIMITED | 2026-04-18 |
| 10304040178857 | Henry Schein | HENRY SCHEIN, INC. | 2024-01-12 |
| 20854137001140 | exofin HVTA ST&G, 1g Box of 10 | Chemence Medical, Inc. | 2022-02-14 |
| 10888277728608 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-11 |
| 00009336010035 | TissueLink | GRAPHIC CONTROLS ACQUISITION CORP | 2021-01-08 |
| 00009336010042 | TissueLink | GRAPHIC CONTROLS ACQUISITION CORP | 2021-01-08 |
| 10884521806191 | Topical Skin Adhesive | Covidien LP | 2020-11-26 |
| 10884389953044 | Medline | MEDLINE INDUSTRIES, INC. | 2020-10-30 |
| 10885632077470 | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | 2019-03-11 |
| 10885380167072 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-02-28 |
| 20612479232260 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-01-08 |
| 00008626160003 | ACTABOND™ Topical Skin Adhesive | BERGEN MEDICAL PRODUCTS, INC. | 2017-03-17 |
| 10884521196773 | SwiftSet | Covidien LP | 2017-01-07 |
| 10612479208206 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479208183 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 00304040006405 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 00304040006382 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 10885632134326 | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | 2016-08-20 |
| 10885632134333 | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | 2016-08-20 |
| 10885632137006 | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | 2016-08-20 |
| 10885380109782 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-08-15 |
| 10885380109775 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-08-15 |
| 10885380109768 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-08-15 |
| 10885380109751 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-08-15 |
| 10885380101588 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-08-15 |
| M495ST050S1 | SurgiSeal | ADHEZION BIOMEDICAL, LLC | 2016-05-19 |
| M495SS050S1 | SurgiSeal | ADHEZION BIOMEDICAL, LLC | 2016-05-18 |
| M495SS035T1 | SurgiSeal | ADHEZION BIOMEDICAL, LLC | 2016-05-18 |