Atlas FDA

FZT

52 FDA 510(k) clearances · Product code

20 daysmedian time to decision
29 days90th percentile
52clearances measured

FDA profile

Official device name
Cutter, Surgical
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 63 · 2022: 76 · 2023: 58 · 2024: 84 · 2025: 57 · 2026: 17
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
SMARTSHEARS (K112400)Nuscience Consulting and Management Group, LLC2011-09-12
AUTO SUTURE DISPOSABLE SURGICAL TROCAR* (K890818)United States Surgical, A Division of Tyco Healthc1989-05-04
MICRINS SURGICAL SCISSOR (K872990)Micrins Surgical, Inc.1987-08-17
SINGLE HAIR TRANSPLANT GRAFT (K841741)Paris Products, Inc.1984-07-23
SPC DISPOSABLE CUTTER (K841247)Surgical Products Corp.1984-05-02
SCISSORS, VARIOUS (K822448)J. Sklar Mfg. Co., Inc.1982-09-14
SURGICAL SCISSORS, SET OF 3 (K821632)Fred Sammons, Inc.1982-06-24
CONPHAR LITTAUER SCISSORS (K821355)Conphar, Inc.1982-05-27
CONPHAR IRIS SCISSORS (K821352)Conphar, Inc.1982-05-27
CONPHAR TONSIL SCISSORS (K821361)Conphar, Inc.1982-05-27
CONPHAR WIRE CUTTING SCISSORS (K821350)Conphar, Inc.1982-05-27
CONPHAR DISSECTING SCISSORS (K821351)Conphar, Inc.1982-05-27
SCISSORS 6 & 1/2 SHARP/BLUNT (K821124)Conphar, Inc.1982-05-07
CONPHAR SCISSORS 4&AHALF SHARPSHARP (K821111)Conphar, Inc.1982-05-07
OPERATING SCISSORS 5 &1/2 SHARP BLUNT& (K821125)Conphar, Inc.1982-05-07
OPERATING SCISSORS 4 & 1/2 BLUNT/BLUNT (K821119)Conphar, Inc.1982-05-07
OPERATING 5 & 1/2 STRAIGH SHARP/BLUNT (K821122)Conphar, Inc.1982-05-07
LISTER BANDAGE SCISSORS 5 & 1/2 (K821116)Conphar, Inc.1982-05-07
LISTER BANDAGE SCISSORS 3 & 1/2 (K821126)Conphar, Inc.1982-05-07
OPERATING SCISSORS 5&1/2 CURVED SHARP (K821113)Conphar, Inc.1982-05-07
SCISSORS CURVED 4 & 1/2 SHARP (K821115)Conphar, Inc.1982-05-07
SCISSORS 5 & 1/2STRAIGHT BLUNT/BLUNT (K821121)Conphar, Inc.1982-05-07
CONPHAR SCISSORS 4&1/2 SHARP BLUNT (K821112)Conphar, Inc.1982-05-07
OPERATING SCISSORS CURVED 4 & 1/2 BLUNT (K821120)Conphar, Inc.1982-05-07
OPERATING SCISSORS CURVED 6 & 1/2 SHARP (K821114)Conphar, Inc.1982-05-07
SCISSORS STRAIGHT 5&1/2SHARP (K821117)Conphar, Inc.1982-05-07
BANDAGE SCISSORS 4 & 1/2 (K821118)Conphar, Inc.1982-05-07
LISTER BANDAGE SCISSORS 7 & 1/2 (K821123)Conphar, Inc.1982-05-07
MED-CARE EMERGENCY SHEARS (K820170)Medcare Products1982-02-05
SUTURE REMOVAL PAK (K801746)Devco Medical Industries, Inc.1980-08-20
SURGICAL STITCH CUTTER (K800103)Macon & Co., Inc.1980-01-28
SCISSOR'S #'S 2294,2262,2263 (K791984)Edward Weck, Inc.1979-10-17
FLOOR LINE INSTRUMENTS (K791741)Edward Weck, Inc.1979-10-04
BROOKS GALL BLADDER SCISSORS (SURG) (K791742)Edward Weck, Inc.1979-10-04
SURGICAL INSTRUMENTS HEIFETZ DIGITATE (K791734)Edward Weck, Inc.1979-09-12
COLOR CODING OF SURGICAL INSTRUMENTS (K790684)Sara Dan, Inc.1979-05-18
ITIMIZED INSTRUMENTS (K790491)E.M. Adams1979-04-04
SUTURE CUTTER (K780574)Laschal Instrument Corp.1978-07-17
LASCHAL SCISSOR (K780575)Laschal Instrument Corp.1978-04-18
FACELIFT SCISSORS (K780152)Edward Weck, Inc.1978-02-02
LAPAROSCOPY DRAPE, BOUNDARY (K772301)Procter & Gamble Mfg. Co.1977-12-20
THOREK SCISSORS 7 1/4 & 10 (K771806)J. Sklar Mfg. Co., Inc.1977-10-04
SURG. SCISSORS FOR CUTTING TISSUE (K771743)Depuy, Inc.1977-09-26
SCISSORS, SURGICAL, 12.5,14,16 & 18 CM. (K770541)Sea-Pac Trading Corp.1977-04-15
SCISSORS, BANDAGE, 15,18,20CM., ANGULAR (K770544)Sea-Pac Trading Corp.1977-04-15
SCISSORS, MAYO _TYLE, 14,16,18,20,22 CM. (K770542)Sea-Pac Trading Corp.1977-04-15
SCISSORS, SURGICAL, ANGULAR, 14 CM. (K770543)Sea-Pac Trading Corp.1977-04-15
CUTTER, P607 BONE (K770305)Dentronix, Inc.1977-03-09
CUTTER, P606 BONE (K770302)Dentronix, Inc.1977-03-09
CUTTER, P605 GENERAL PURPOSE (K770304)Dentronix, Inc.1977-03-09
NIPPER, NAIL, P610 ENGLISH (K770303)Dentronix, Inc.1977-03-09
NIPPER, PSO4 TISSUE (K770301)Dentronix, Inc.1977-03-07

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