510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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DEN170075Unknown

ContainOR

Advanced Surgical Concepts, Bray, IE / Direct, Unknown
FDA source (opens on fda.gov)

DEN170075 is the FDA 510(k) clearance record for ContainOR, a class II device, cleared for Advanced Surgical Concepts, Ltd. on under FDA product code PZQ (General Laparoscopic Power Morcellation Containment System). FDA's definition for product code PZQ reads: "Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures". FDA records list 12 510(k) clearances for Advanced Surgical Concepts, Ltd., from to . As of , FDA records show no recalls naming DEN170075.

Clearance record

Decision date
Received
(81 days to decision)
Product code
PZQ General Laparoscopic Power Morcellation Containment System
Regulation
21 CFR 878.4825
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Advanced Surgical Concepts, Ltd. Unit 4 Sunnybank Center, Upper Dargle Rd., Bray, IE
Third party review
No

Clearances, product code PZQ

Trailing 12 months

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

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