Atlas FDA

GDX

26 FDA 510(k) clearances · Product code

32 daysmedian time to decision
113 days90th percentile
26clearances measured

FDA profile

Official device name
Scalpel, One-Piece
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2006: 3 · 2007: 4 · 2009: 5 · 2010: 3 · 2014: 8 · 2021: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SURGISTAR BLADES (K923689)Surgistar, Inc.1992-09-09
ULTRABLADE (K921167)Micron Technology, Inc.1992-07-30
ICAN CYLINDRICAL SPONGES (K914086)Icn Pharmaceuticals, Inc.1991-10-09
CCI CORNEAL SCARIFIER (K904505)Buckman Co., Inc.1991-04-23
1-CUT ACL GRAFT KNIFE (K905380)Depuy, Inc.1990-12-13
VESSEL LOOPS (K895682)Applied Medical Technologies1989-10-24
MINI-DIAMOND KNIFE (K893033)L.A.B. Instruments1989-05-26
OMED DISPOSABLE SCALPEL (K880028)Oxboro Medical Intl., Inc.1988-01-29
KCK INDUSTRIES' SURGICAL INSTRUMENTS (K871894)Kck Industries1987-06-23
P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL (K863950)Precision Surgical Industries, Inc.1986-10-24
KEISEI SCALPEL (STERILE AND NON-STERILE) (K863213)Keisei Medical Industrial Co., Ltd.1986-09-02
SCALPEL, ONE-PIECE, DISPOSABLE (K854857)Medelec Intl. Corp.1985-12-24
MCKNIFE (K853103)Medical Dimensions1985-08-06
7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1 (K851751)Artiberia1985-06-20
SURE-CUT (K833467)Diverse Technologies, Inc.1984-01-27
H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 (K834541)Imm Enterprises , Ltd.1984-01-27
ADT DISPOSABLE SCALPEL W/STAINLESS STEEL (K830745)Lab Industries, Inc.1983-04-12
G.E.V. DISPOSABLE SCALPELS (K822893)Ascep, Inc.1982-10-22
PILLING DIAMOND KNIFE (K822749)Narco Scientific1982-10-06
DISPOSABLE #11 SCALPEL BLADE W/SHORT (K820869)Van-Tec, Inc.1982-05-05
MICRO CISE DIAMOND SCALPEL (K820730)CooperVision, Inc.1982-04-09
SCALPEL (K813422)Abco Dealers, Inc.1982-01-05
AXICUT DISPOSABLE SCALPEL (K811707)Neonatal Corp.1981-07-20
I.M. BLADES (K800177)Instrument Makar, Inc.1980-02-11
STERILE DISPOSABLE KNIFE (K790259)Intermedics, Inc.1979-02-13
SCALPEL (K780998)Isolab, Inc.1978-07-27

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