510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K160595Substantially Equivalent

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

Pms Medikal Ambalaj Sanayi ve Ticaret Ltd Sti, Mersin, TR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160595 is the FDA 510(k) clearance record for PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator, a class II device, cleared for Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti on under FDA product code FRG (Wrap, Sterilization). FDA records list one 510(k) clearance for Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti. As of , FDA records show no recalls naming K160595.

Clearance record

Decision date
Received
(262 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti Karaduvar Mah.Serbest Bolge, 11.Cad #46, Mersin, TR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260