K935639 is the FDA 510(k) clearance record for INSUFFLATION TUBING STERILE AND NON-STERILE, a class II device, cleared for Charles Polo & Co., Inc. on 1994-03-17 under FDA product code HIF (Insufflator, Laparoscopic). FDA records list 2 510(k) clearances for Charles Polo & Co., Inc., from 1988-06-15 to 1994-03-17 . As of 2026-09-10 , FDA records show no recalls naming K935639.
Clearance record Decision date 1994-03-17 Received 1993-11-23 (114 days to decision) Product code HIF Insufflator, LaparoscopicRegulation 21 CFR 884.1730 Device class Class II Review panel Obstetrics/Gynecology Applicant Charles Polo & Co., Inc. 12714 Hoover St., Garden Grove CA 510(k) summary Statement Third party review No
Clearances, product code HIF Trailing 12 months 3 clearances under product code HIF in the twelve months to October 2026, April 2026 the highest month at 1. 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 HIF
Z-2776-2026 Class II Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases. Olympus Corporation of the Americas / initiated 2026-06-16 / 3,087 units Z-2474-2026 Class II Potential for overpressure alerts. ConMed Corporation / initiated 2026-05-14 / 147,013 packs (882,078 eaches) Z-2473-2026 Class II Potential for overpressure alerts. ConMed Corporation / initiated 2026-05-14 / 71,151 packs (426,908 eaches) Z-2472-2026 Class II Potential for overpressure alerts. ConMed Corporation / initiated 2026-05-14 / 3,550 packs (21,300 eaches) Z-2471-2026 Class II Potential for overpressure alerts. ConMed Corporation / initiated 2026-05-14 / 36,462 packs (219,850 eaches) Z-2470-2026 Class II Potential for overpressure alerts. ConMed Corporation / initiated 2026-05-14 / 32,792 packs (196,751 eaches)
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)
