K954311 is the FDA 510(k) clearance record for KOH COLPOTOMIZER SYSTEM, a class II device, cleared for CooperSurgical, Inc. on 1996-11-19 under FDA product code HEW (Culdoscope (And Accessories)). FDA records list 103 510(k) clearances for CooperSurgical, Inc., from 1981-02-04 to 2026-01-20 . As of 2026-09-10 , FDA records show 2 recalls naming K954311.
Clearance record Decision date 1996-11-19 Received 1995-09-15 (431 days to decision) Product code HEW Culdoscope (And Accessories)Regulation 21 CFR 884.1640 Device class Class II Review panel Obstetrics/Gynecology Applicant CooperSurgical, Inc. 49 Plain St., North Attleboro MA 510(k) summary Summary Third party review No
Clearances, product code HEW Trailing 12 months FDA records hold no clearances under product code HEW in the trailing twelve months.
FDA records show no clearances under product code HEW in the twelve months to October 2026. Show the numbers FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
Product code HEW
Z-1686-2021 Class II The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N... CooperSurgical, Inc. / initiated 2021-04-23 / 6 boxes or 12 units Z-1978-2019 Class II The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive... CooperSurgical, Inc. / initiated 2019-06-14 / 213 units in total Z-1977-2019 Class II The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive... CooperSurgical, Inc. / initiated 2019-06-14 / 213 units in total Z-0098-2019 Class II The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. CooperSurgical, Inc. / initiated 2018-09-04 / 32538
MDM coverage of this record lists here, newest first.
About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
