510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K233020Substantially Equivalent

TauTona Pneumoperitoneum Assist Device (TPAD)

Tautona Group Research & Development, Co., LLC, Redwood City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233020 is the FDA 510(k) clearance record for TauTona Pneumoperitoneum Assist Device (TPAD), a class II device, cleared for Tautona Group Research & Development, Co., LLC on under FDA product code HIF (Insufflator, Laparoscopic). FDA records list one 510(k) clearance for Tautona Group Research & Development, Co., LLC. As of , FDA records show no recalls naming K233020.

Clearance record

Decision date
Received
(112 days to decision)
Product code
HIF Insufflator, Laparoscopic
Regulation
21 CFR 884.1730
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Tautona Group Research & Development, Co., LLC 604 Fifth Ave., Redwood City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIF

Trailing 12 months
3 clearances under product code HIF in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260