Product code MDM
- Device name
- Instrument, Manual, Surgical, General Use
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073664 | FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER | Injectimed, Inc. | 2008-08-08 |
| K050575 | FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM | Futumeds Sdn Bhd | 2005-08-15 |
| K050957 | EUTROCHAR | Special Devices, Inc. | 2005-05-18 |
| K023173 | ANDREWS INTRODUCER, MODEL ASI01 | Andrews Surgical Innovations, Ltd. | 2002-12-18 |
| K022059 | MICROVASIVE PULMONARY GUIDEWIRE | Boston Scientific Corp | 2002-11-13 |
| K013040 | LIGHT SABER INTRODUCER NEEDLE | Minrad, Inc. | 2001-12-07 |
| K010184 | CHESS HAND SURGERY SYSTEM | Canica Design, Inc. | 2001-06-22 |
| K990062 | SAPHLIFT | Genzyme Surgical Product (Genzyme Biosurgery) | 1999-03-30 |
| K981579 | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG | ETHICON, Inc. | 1998-07-09 |
| K943968 | TUNNELER | Denver Biomedicals, Inc. | 1995-03-01 |
| K945430 | DERMAVBLADE(TM) | Hasting'S Biomedical Corp. | 1994-11-28 |
| K941193 | EAST WEST INSTRUMENTS | East West Instruments, Inc. | 1994-11-09 |
| K941907 | APEX DISPOSABLE INSTRUMENTS | Apex Ent., Inc. | 1994-08-26 |
| K942818 | DEEP SUTURE | Automated Medical Products Corp. | 1994-08-25 |
| K942896 | CLAMPS AND CLIPS | Surgin Surgical Instrumentation, Inc. | 1994-07-19 |
| K940684 | SURGICAL INSTRUMENT, DISPOSABLE | Her-Mar, Inc. | 1994-03-14 |
| K933265 | ACU-DISPO-CE(TM) | Acuderm, Inc. | 1994-03-07 |
| K933866 | ACU-HEMOSTATIC RING | Acuderm, Inc. | 1993-12-01 |
| K925653 | DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH | Dermatopathology Laboratory | 1993-11-08 |
| K922130 | HOSPITAL KIT DK 117 | Savoy Medical Supply Co., Inc. | 1993-05-24 |
| K926126 | SUTUREMATE | Surgical Safety Products, Inc. | 1993-05-19 |
| K930775 | DISPOSABLE FORCEPS, HEMOSTATS, NEEDLE GUIDES, ETC | Falcon Instruments, Inc. | 1993-04-23 |
| K922127 | HOSPITAL KIT GP 103 | Savoy Medical Supply Co., Inc. | 1993-03-29 |
| K923281 | SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT | Savoy Medical Supply Co., Inc. | 1993-03-26 |
| K922128 | HOSPITAL KIT EP 104 | Savoy Medical Supply Co., Inc. | 1993-03-23 |
| K925874 | BREAST STABILIZER | Bip USA, Inc. | 1993-03-16 |
| K930399 | ORC ENDOSCOPIC INSTRUMENT HOLDER | O.R. Concepts, Inc. | 1993-02-17 |
| K924503 | PERSONNA SAFETY SCALPEL | American Safety Razor Co. | 1993-02-05 |
| K924725 | AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS | American Biomaterials Corp. | 1993-02-05 |
| K923812 | CENTURION DISPOSABLE INSTRUMENTS | Tri-State Hospital Supply Corp. | 1992-12-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20888277688978 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-27 |
| 10888277689244 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-27 |
| 10888277689237 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-27 |
| 10888277689220 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-27 |
| 10888277689213 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-27 |
| 10888277689206 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-27 |
| 10888277689190 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-27 |
| 10888277688988 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-27 |
| 10080196321407 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-25 |
| 10888277689183 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-25 |
| 10080196321483 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-25 |
| 10080196321476 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-25 |
| 10080196321469 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-25 |
| 10080196321452 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-25 |
| 10080196321438 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-25 |
| 10080196321414 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-25 |
| 10080196320899 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-25 |
| 10080196321490 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-25 |
| 10080196321445 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-24 |
| 00190776431587 | Millennium | Avalign Technologies, Inc. | 2026-09-22 |
| 00850088713893 | PRINCETON | Princeton Medical Group, Inc. | 2026-09-22 |
| 00850088713886 | PRINCETON | Princeton Medical Group, Inc. | 2026-09-22 |
| 00888867574489 | Arthrex® | ARTHREX, INC. | 2026-09-18 |
| 10888277688995 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-14 |
| 00190776400477 | Millennium | Avalign Technologies, Inc. | 2026-07-17 |
| 07613327524000 | LITe Bio | Stryker Corporation | 2021-03-03 |
| 14026704630735 | PILLING | TELEFLEX INCORPORATED | 2019-05-30 |
| 00888867131538 | Arthrex® | ARTHREX, INC. | 2018-08-03 |
| 07613327175752 | LITe BIO Delivery System | Stryker Corporation | 2016-08-15 |
| 07613327175776 | LITe BIO Delivery System | Stryker Corporation | 2016-08-15 |