K812694 is the FDA 510(k) clearance record for WHISK-R, a class I device, cleared for Medi-Spec on 1981-10-26 under FDA product code GEE (Brush, Biopsy, General & Plastic Surgery). FDA records list 8 510(k) clearances for Medi-Spec, from 1978-08-21 to 1984-02-04 . As of 2026-09-10 , FDA records show no recalls naming K812694.
Clearance record Decision date 1981-10-26 Received 1981-09-22 (34 days to decision) Product code GEE Brush, Biopsy, General & Plastic SurgeryRegulation 21 CFR 878.4800 Device class Class I Review panel General, Plastic Surgery Applicant Medi-Spec 803 N. Front St. Suite 3, Mchenry IL Third party review No
Clearances, product code GEE Trailing 12 months FDA records hold no clearances under product code GEE in the trailing twelve months.
FDA records show no clearances under product code GEE 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 GEE
FDA records show no recalls under product code GEE.
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)
