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Anchor Tissue Retrieval System

by Conmed Corporation EUDAMED510(k)GUDID

Active United States and European Union

Ref TRS070, TRS100SB2, TRS080, TRS-ROBO-12, TRS090, TRS-ROBO-8, TRS-TV-25510(k) K173822

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-20653405986079 Basic UDI-DIDate3 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20653405986079 UDI-DIDate15 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK173822 Date11 Sep 2018ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1308-2019 FDA Class II initiated 21 Mar 2019
    • Terminated Z-1307-2019 FDA Class II initiated 21 Mar 2019
    • Terminated Z-1306-2019 FDA Class II initiated 21 Mar 2019
    • Terminated Z-1305-2019 FDA Class II initiated 21 Mar 2019
    • Terminated Z-1309-2019 FDA Class II initiated 21 Mar 2019
    • Terminated Z-1304-2019 FDA Class II initiated 21 Mar 2019

    Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Anchor Tissue Retrieval System EUDAMEDGUDID
anchor, Bag-Alone GUDID
Generic Name
Tissue extraction bag
Device Name
Non-orthopedic, Non-active, Instrument, Tissue Retrieval, Laparoscopic
Non-orthopedic, Non-active, Instrument, Tissue Retrieval, Transvaginal
Model / Ref / Catalog
TRS070, TRS100SB2, TRS080, TRS-ROBO-12, TRS090, TRS-ROBO-8, TRS-TV-25
Primary DI / UDI-DI
20653405986079, 20653405986109, 20653405986123, 20653405986154, 20653405986093, 20653405986147, 20653405986178
Basic UDI-DI
B-20653405986079, B-20653405986109, B-20653405986123, B-20653405986154, B-20653405986093, B-20653405986147, B-20653405986178
510(k) Number
FDA Product Code
GCJ
EMDN Code
K01020107 Minimally invasive surgery recovery bags
GMDN Term
Tissue extraction bag
Device Class
Class IIa EUDAMED
Class I EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 876.1500
Market of Registration
Belgium
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class IIa
Class I
510(k)
Class II
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No