510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K953132Substantially Equivalent

Uimat Pump

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

K953132 is the FDA 510(k) clearance record for UIMAT PUMP, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K953132.

Clearance record

Decision date
Received
(48 days to decision)
Product code
BTA Pump, Portable, Aspiration (Manual Or Powered)
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
KARL STORZ Endoscopy-America, Inc. 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary
Third party review
No

Clearances, product code BTA

Trailing 12 months
7 clearances under product code BTA in the twelve months to November 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code BTA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20261
May 20264
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260