Atlas FDA

HAM

31 FDA 510(k) clearances · Product code

25 daysmedian time to decision
90 days90th percentile
31clearances measured

FDA profile

Official device name
Apparatus, Electrosurgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
Adverse events (MAUDE)
1992: 4 · 1994: 3 · 1995: 1 · 2000: 1 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Quiver Laparoscopic Extendable (K153472)Itl Corporation Pty, Ltd.2016-06-23
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M (K000079)Nikomed U.S.A., Inc.2000-02-04
NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) (K993306)Paladin Medical, Inc.1999-11-03
BERGEN 710 ESU (K945861)Bergen Mfg.1995-03-01
LAPAROSTAT(TM) (K913300)Cook Ob/Gyn1992-04-02
GSU HANDPIECE ADAPTER (K920100)Beacon Laboratories, Inc.1992-02-03
EMC MODEL NO. STATOME 900 (K911353)Emc Industries1991-06-24
ABC HANDPIECE ADAPTER (K901248)Beacon Laboratories, Inc.1990-04-03
LIGHT COAGULATOR LC 250 (K881334)Nk-Optik GmbH1989-11-16
ELECTROSURGICAL COAGULATION SUCTION TUBE (K895337)New England Surgical Instrument Corp.1989-09-15
BEAMER ONE (K894663)Beacon Laboratories, Inc.1989-09-15
B100 DISPOSABLE HANDPIECE (K894762)Beacon Laboratories, Inc.1989-09-15
#875 DISPOSABLE BIOPOLAR CABLE (K884171)Olsen Electrosurgical, Inc.1988-10-24
MODIFIED OLSEN 755/756 SWITCHPENS (K884174)Olsen Electrosurgical, Inc.1988-10-24
MODIFIED OLSEN #770 DISPOSABLE HOLSTER (K884172)Olsen Electrosurgical, Inc.1988-10-24
#920 DISPOSABLE TUR CABLE (K884173)Olsen Electrosurgical, Inc.1988-10-24
#820/821 BIPOLAR FORCEPS (K884175)Olsen Electrosurgical, Inc.1988-10-24
BARD EMS SYSTEM 6000 E.S.U. (K871435)C.R. Bard, Inc.1987-05-11
BICORD BY QMED (K863091)Qmed, Inc.1986-08-29
GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 (K853291)Bio-Detek, Inc.1985-10-10
ELECTRO-CAUTERY KNIFE CLEANER 6000 1 (K852184)Dlp, Inc.1985-06-04
OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S (K833648)Edward Weck, Inc.1983-11-29
BICEPS ELECTROCAUTERY SYSTEM (K823755)Squibb Diagnostics1983-01-26
DISPOSABLE ELECTRODE (K820664)Trident Surgical Corp.1982-03-19
NDM DIATEMP INFANT ELECTROSURG. DISP. P. (K810920)Ndm Corp.1981-05-01
MICRO CAUTERY (K810909)Key Medical, Inc.1981-04-17
MULTIHI-TEMP CAUTERY (K810015)Medical Products Development, Inc.1981-02-12
REPLACABLE BATTERY HI-TEMP CAUTERY (K810014)Medical Products Development, Inc.1981-02-12
ELECTROSURGICAL UNIT (K780293)Ritter Co.1978-03-14
ELECTRODE, DISPERSIVE, DISP. NEOPAD (K780118)Neomed Corp.1978-02-23
MICRO BI-POLAR FORCEPS #39-200 (K771186)Edward Weck, Inc.1977-07-15

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