510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153422Substantially Equivalent

Panpac Disposable Pessary Fitting Set

Panpac Medical Corporation, Shi-Chih Dist., TW / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K153422 is the FDA 510(k) clearance record for Panpac Disposable Pessary Fitting Set, a class II device, cleared for Panpac Medical Corporation on under FDA product code HHW (Pessary, Vaginal). FDA records list 12 510(k) clearances for Panpac Medical Corporation, from to . As of , FDA records show no recalls naming K153422.

Clearance record

Decision date
Received
(232 days to decision)
Product code
HHW Pessary, Vaginal
Regulation
21 CFR 884.3575
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Panpac Medical Corporation 6f-1,2, # 202, Sec.3, Ta-Tong Rd., Shi-Chih Dist., TW
510(k) summary
Statement
Third party review
No

Clearances, product code HHW

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