ENDOSCOPE AND ACCESSORIES— 510(k) K790071

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K790071 for ENDOSCOPE AND ACCESSORIES, Substantially Equivalent on 1979-04-02. Applicant: Olympus Corp.. Device class: 2.

Clearance details

Applicant: Olympus Corp.
Product code: Code GCP
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1979-01-11
Decision date: 1979-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCP

K954614 — EOS BRAND DISPOSABLE PROCTOSCOPE1996-04-10
K896505 — PORGES UNIVERSAL HANDLES1990-01-30
K896008 — MODEL 6500 MERCURY ARC LIGHT SOURCE1989-12-27
K862424 — STEERABLE CATHETER SYSTEM1986-09-22
K860103 — MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE1986-02-12

More clearances from Olympus Corp.

K915402 — EW-10 AND EW-201995-06-23
K933200 — OLYMPUS PBD STENTS1995-04-05
K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES1994-11-30
K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS1994-08-29
K934835 — FLOVAL1994-06-21

Recalls naming K790071

K-number listed on FDA's recall record

Z-1454-2026 — Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.Class II·Ongoing·Olympus Corporation of the Americas·20251111
Z-0351-2025 — Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/AClass II·Ongoing·Olympus Corporation of the Americas·20240913
Z-1437-2026 — Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;Class II·Ongoing·Olympus Corporation of the Americas·20240913
Z-0696-2018 — A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.Class II·Terminated·Olympus Corporation of the Americas·20170818
Z-2629-2017 — High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.Class II·Terminated·Olympus Corporation of the Americas·20170419

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K790071.

Data sourced from openFDA. This site is unofficial and independent of the FDA.