Product code FHQ— Gastroenterology, Urology

FDA has cleared 7 devices under product code FHQ between 1977 and 1998, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19981 clearance
• 19933 clearances
• 19852 clearances
• 19771 clearance

• Artiberia2 clearances
• Retrax1 clearance
• Phx Technologies Corp.1 clearance
• Nusurg, Inc.1 clearance
• Holmed Corp.1 clearance
• Edward Weck, Inc.1 clearance

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K974327 — WINGED NEEDLE HOLDERPhx Technologies Corp.·1998-01-09
• K924196 — LAPAROSCOPIC NEEDLE HOLDERNusurg, Inc.·1993-06-25
• K930330 — ENDOSCOPIC NEEDLEHOLDER, MODIFICATIONHolmed Corp.·1993-06-08
• K920706 — MAGNETIC POINT GUARD FOR SURGICAL NEEDLESRetrax·1993-05-26
• K851779 — 25-100,25-220 VARIOUS NEEDLE HOLDERSArtiberia·1985-06-20
• K851780 — 25-230 TO 25-390 VARIOUS NEEDLE HOLDERSArtiberia·1985-06-20
• K771859 — NEEDLE HOLDER, MICROVASCULAREdward Weck, Inc.·1977-10-04