510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K963852Substantially Equivalent

Ksea Thermocoagulator (Model 265100 20)

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

K963852 is the FDA 510(k) clearance record for KSEA THERMOCOAGULATOR (MODEL 265100 20), a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code HGI (Electrocautery, Gynecologic (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 K963852.

Clearance record

Decision date
Received
(76 days to decision)
Product code
HGI Electrocautery, Gynecologic (And Accessories)
Regulation
21 CFR 884.4120
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
KARL STORZ Endoscopy-America, Inc. 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary
Third party review
No

Clearances, product code HGI

Trailing 12 months

FDA records hold no clearances under product code HGI in the trailing twelve months.

FDA records show no clearances under product code HGI in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HGI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260