Atlas FDA

GDT

19 FDA 510(k) clearances · Product code

42 daysmedian time to decision
234 days90th percentile
19clearances measured

FDA profile

Official device name
Staple, Removable (Skin)
Device class
Class I (low risk)
Regulation
21 CFR 878.4760
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 251 · 2022: 98 · 2023: 72 · 2024: 51 · 2025: 109 · 2026: 49
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
STAPLE REMOVAL KIT (K963234)Continental Medical Laboratories, Inc.1996-10-21
VISISTAT STAPLER (K943719)Pilling Weck, Inc.1994-08-24
MANIPLER DISPOSABLE SKIN STAPLER (K925526)Matsutani Seisakusho Co. , Ltd.1993-06-24
SKIN STAPLE REMOVER KIT (K915430)Cypress Medical Products, Ltd.1992-02-28
QUALTEX SKIN STAPLE EXTRACTOR (K911204)Deroyal Industries, Inc.1991-05-08
AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* (K910586)United States Surgical, A Division of Tyco Healthc1991-03-07
APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER (K900486)Davis & Geck, Inc.1990-04-20
SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE (K861711)Busse Hospital Disposables, Inc.1986-05-16
V. MUELLER VITAL SKIN STAPLER (K851974)American V. Mueller1985-06-11
SKIN STAT II SKIN STAPLING MEDICAL DEVICE (K844838)Edward Weck, Inc.1985-01-23
VISISTAT SKIN STAPLING DEVICE (K844837)Edward Weck, Inc.1985-01-23
STAPLE REMOVER SR300P (K833085)Prosper, Inc.1984-12-14
VYDAX 525-550 & 5100 FLUOROTELOMER (K833357)ETHICON, Inc.1983-12-12
SKIN STAPLING DEVICE SC2000 (K832709)Prosper, Inc.1983-09-26
CENTURION SKIN STAPLE REMOVER (K822365)Tri-State1982-08-27
DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE (K821024)Howmedica Corp.1982-05-14
SKIN STAPLE REMOVER #523770 (K801444)Edward Weck, Inc.1980-07-14
3M DISPOSABLE SKIN STAPLER (K800535)3M Company1980-04-04
REGULAR AND WIDE SKIN STAPLES (K760734)ETHICON, Inc.1976-11-03

Track GDT automatically

Every clearance here is in the API, with alerts when new ones post.