510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K882270Substantially Equivalent

Models 27040 & 27050 Conti. Flow Resectoscopes

Karl Storz Endoscopy-America, Inc., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882270 is the FDA 510(k) clearance record for MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code HIH (Hysteroscope (And Accessories)). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K882270.

Clearance record

Decision date
Received
(507 days to decision)
Product code
HIH Hysteroscope (And Accessories)
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
KARL STORZ Endoscopy-America, Inc. 10111 W. Jefferson Blvd., Culver City CA
Third party review
No

Clearances, product code HIH

Trailing 12 months
8 clearances under product code HIH in the twelve months to November 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code HIH, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20261
September 20263
October 20260
November 20260