K920706 is the FDA 510(k) clearance record for MAGNETIC POINT GUARD FOR SURGICAL NEEDLES, a class I device, cleared for Retrax on 1993-05-26 under FDA product code FHQ (Holder, Needle, Gastroenterologic). FDA records list 2 510(k) clearances for Retrax, from 1990-06-14 to 1993-05-26 . As of 2026-09-10 , FDA records show no recalls naming K920706.
Clearance record Decision date 1993-05-26 Received 1992-02-18 (463 days to decision) Product code FHQ Holder, Needle, GastroenterologicRegulation 21 CFR 876.4730 Device class Class I Review panel Gastroenterology, Urology Applicant Retrax 800 W. Wausau Cir., Wausau WI 510(k) summary Summary Third party review No
Clearances, product code FHQ Trailing 12 months FDA records hold no clearances under product code FHQ in the trailing twelve months.
FDA records show no clearances under product code FHQ 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 FHQ
Z-2767-2020 Class II The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under... Boss Instruments, Ltd. / initiated 2020-06-26 / 96 devices Z-2534-2020 Class II Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under... Dufner Instrumente GmbH / initiated 2020-06-03 / 30 units Z-2313-2017 Class II COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide... Cook Inc. / initiated 2017-05-01 / 327 Lots, 725 units Z-1948-2009 Product sterility may be compromised due to lack of package integrity. Davol, Inc., Sub. C. R. Bard, Inc. / initiated 2009-07-30 / 1,140 units
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)
