PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS— 510(k) K945209

Name: FDA 510(k) clearance K945209
Creator: U.S. Food and Drug Administration
Published: 1995-03-06

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K945209 for PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS, Substantially Equivalent on 1995-03-06. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code GCF
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1994-10-25
Decision date: 1995-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCF

view all

K790856 — PROCTOSCOPE #5011979-05-29

More clearances from KARL STORZ Endoscopy-America, Inc.

view all

K252624 — KARL STORZ Laryngoscopes and Accessories2026-05-15
K240506 — KARL STORZ Holders2024-10-22
K223885 — HOPKINS Telescopes2023-09-14
K230359 — KOH Ultramicro Injection Cannula (26167NN) +11 more2023-06-23
K223520 — UNIDRIVE SIII System2023-04-27

Recalls naming K945209

K-number listed on FDA's recall record

Z-0571-2024 — Injection Needle, REF: 25207Class II·Ongoing·Karl Storz Endoscopy·20231024

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K945209.

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