K864019 is the FDA 510(k) clearance record for NEEDLE NOSE PLIERS, a class I device, cleared for Med-Tool, Inc. on 1986-10-30 under FDA product code HTC (Pliers, Surgical). FDA records list 28 510(k) clearances for Med-Tool, Inc., from 1984-04-25 to 1987-11-23 . As of 2026-09-10 , FDA records show no recalls naming K864019.
Clearance record Decision date 1986-10-30 Received 1986-10-15 (15 days to decision) Product code HTC Pliers, SurgicalRegulation 21 CFR 878.4800 Device class Class I Review panel General, Plastic Surgery Applicant Med-Tool, Inc. 12434 Matthews Ln., St. Louis MO Third party review No
Clearances, product code HTC Trailing 12 months FDA records hold no clearances under product code HTC in the trailing twelve months.
FDA records show no clearances under product code HTC 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 HTC
Z-1017-2016 Class II May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start. The Anspach Effort, Inc. / initiated 2014-11-14 / 302 (23 in the USA and 279 OUS) Z-0931-2015 Class II The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start... Synthes (USA) Products LLC / initiated 2014-11-06 / 12 Z-0747-2016 Class II The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not... The Anspach Effort, Inc. / initiated 2014-08-14 / 599 each Z-0076-2010 The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification. Synthes USA (HQ), Inc. / initiated 2009-09-03 / 4
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)
