Atlas FDA

GCM

18 FDA 510(k) clearances · Product code

111 daysmedian time to decision
481 days90th percentile
18clearances measured

FDA profile

Official device name
Endoscope, Rigid
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
1996: 6 · 1997: 1 · 2024: 449 · 2025: 616 · 2026: 392
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM (K203226)Richard Wolf Medical Instruments Corporation2021-05-14
MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE (K083840)Msi Medserv International Deutschland GmbH2009-09-28
INSIDE VIEW (K001217)Monadnock Optics, Inc.2000-07-11
ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES (K993103)Richard Wolf Medical Instruments Corp.1999-12-10
OMNISONIC ENDOSCOPIC DEFLECTOR (K993445)Omnisonics Medical Technologies1999-12-06
KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION (K962393)KARL STORZ Endoscopy-America, Inc.1996-09-17
PORTABLE ENDOSCOPY SYSTEM (K950712)Laser-Optik-Systeme GmbH & Co. KG1996-05-14
HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR (K955120)Ethicon Endo-Surgery, Inc.1996-01-26
ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY (K935235)Smith & Nephew Richards, Inc.1995-03-23
KARL STORZ PLASTIC SURGERY ACCESSORIES (K945889)KARL STORZ Endoscopy-America, Inc.1995-03-22
THORACOSCOPE/LAPAROSCOPE (K931954)Surgical Technologies, Inc.1993-11-02
FIBER OPTIC ENDOSCOPE (K921918)Electro Fiberoptics Corp.1993-08-17
PRESSURE TURING AND ACCESSORIES (K925918)Applied Medical Resources1993-02-12
ENDOSCOPE (K921883)Optimed Technologies, Inc.1992-11-23
MEDILASE SERIES 2200 ENDOSCOPE (K901464)Medical Laser, Inc.1990-08-07
LAMANO DIRECTORS (K894592)Marlo Surgical Technology1989-09-08
RIGID ENDOSCOPE (K853514)American Edwards Laboratories1985-10-04
RIGID FIBEROPITC ENDOSCOPE (K844769)Microvasive1985-01-15

Track GCM automatically

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