510(k) K161011
- Device
- SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
- Applicant
- Adhezion Biomedical, LLC
- 510(k) number
- K161011
- Product code
- MPN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-11-08
- Date received
- 2016-04-11
- Regulation
- 878.4010
- Classification name
- Tissue Adhesive For The Topical Approximation Of Skin
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Richard Jones
- Address
- One Meridian Blvd., Suite 1b02 Wyomissing PA US 19610 19610
FDA Registration Numbers#
- 3013188547
- 3003639970
- 3017102971
- 1055236
- 3010034760
- 1450662
- 1047843
- 2438948
- 3031294900
- 1061124
- 3002807314
- 9681465
- 3002807315
- 3043226252
- 2648650
- 3009656988
- 3008132398
- 3014421917
- 3014637532
- 1043214
- 3018094310
- 2246552
- 1219930
- 3006385287
- 3007205024
- 3012494290
- 3025308493
- 1064858
- 3004530184
- 2320762
- 2210968
- 9615414
- 1054241
- 3009380063
- 9610612
- 9617175
Source Documents#
Other 510(k) Records For Product Code MPN #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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