GDT · Staple, Removable (Skin)
General, Plastic Surgery · 21 CFR 878.4760 · Class 1
Overview
| Product Code | GDT |
|---|---|
| Device Name | Staple, Removable (Skin) |
| Regulation | 21 CFR 878.4760 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K963234 | STAPLE REMOVAL KIT | Continental Medical Laboratories, Inc. | Oct 21, 1996 | SESE |
| K943719 | VISISTAT STAPLER | Pilling Weck, Inc. | Aug 24, 1994 | SESE |
| K925526 | MANIPLER DISPOSABLE SKIN STAPLER | Matsutani Seisakusho Co. , Ltd. | Jun 24, 1993 | SESE |
| K915430 | SKIN STAPLE REMOVER KIT | Cypress Medical Products, Ltd. | Feb 28, 1992 | SEKD |
| K911204 | QUALTEX SKIN STAPLE EXTRACTOR | Deroyal Industries, Inc. | May 8, 1991 | SESE |
| K910586 | AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* | United States Surgical, A Division of Tyco Healthc | Mar 7, 1991 | SESE |
| K900486 | APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER | Davis & Geck, Inc. | Apr 20, 1990 | SESE |
| K861711 | SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE | Busse Hospital Disposables, Inc. | May 16, 1986 | SESE |
| K851974 | V. MUELLER VITAL SKIN STAPLER | American V. Mueller | Jun 11, 1985 | SESE |
| K844838 | SKIN STAT II SKIN STAPLING MEDICAL DEVICE | Edward Weck, Inc. | Jan 23, 1985 | SESE |
| K844837 | VISISTAT SKIN STAPLING DEVICE | Edward Weck, Inc. | Jan 23, 1985 | SESE |
| K833085 | STAPLE REMOVER SR300P | Prosper, Inc. | Dec 14, 1984 | SESE |
| K833357 | VYDAX 525-550 & 5100 FLUOROTELOMER | ETHICON, Inc. | Dec 12, 1983 | SESE |
| K832709 | SKIN STAPLING DEVICE SC2000 | Prosper, Inc. | Sep 26, 1983 | SESE |
| K822365 | CENTURION SKIN STAPLE REMOVER | Tri-State | Aug 27, 1982 | SESE |
| K821024 | DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE | Howmedica Corp. | May 14, 1982 | SESE |
| K801444 | SKIN STAPLE REMOVER #523770 | Edward Weck, Inc. | Jul 14, 1980 | SESE |
| K800535 | 3M DISPOSABLE SKIN STAPLER | 3M Company | Apr 4, 1980 | SESE |
| K760734 | REGULAR AND WIDE SKIN STAPLES | ETHICON, Inc. | Nov 3, 1976 | SESE |
Top Applicants
- Edward Weck, Inc. — 3 clearances
- ETHICON, Inc. — 2 clearances
- Prosper, Inc. — 2 clearances
- 3M Company — 1 clearance
- American V. Mueller — 1 clearance
