DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE)— 510(k) K914910

Name: FDA 510(k) clearance K914910
Creator: U.S. Food and Drug Administration
Published: 1992-01-06

Substantially Equivalent

Davol, Inc.

FDA 510(k) clearance K914910 for DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE), Substantially Equivalent on 1992-01-06. Applicant: Davol, Inc.. Device class: 2.

Clearance details

Applicant: Davol, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1991-11-01
Decision date: 1992-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranston, RI, US

Download summary PDF View on FDA.gov ↗

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K030307 — DAVOL ARTHROVENT OUTFLOW TUBING2003-02-13
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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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 →

Recalls naming K914910

K-number listed on FDA's recall record

Z-1893-2025 — Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5860020.Class II·Ongoing·Silex Medical, LLC·20240109
Z-1894-2025 — Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030.Class II·Ongoing·Silex Medical, LLC·20240109
Z-1895-2025 — Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100.Class II·Ongoing·Silex Medical, LLC·20240109
Z-1896-2025 — Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020.Class II·Ongoing·Silex Medical, LLC·20240109
Z-1897-2025 — Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.Class II·Ongoing·Silex Medical, LLC·20240109
Z-1898-2025 — Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050.Class II·Ongoing·Silex Medical, LLC·20240109
Z-1899-2025 — Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.Class II·Ongoing·Silex Medical, LLC·20240109
Z-1900-2025 — Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.Class II·Ongoing·Silex Medical, LLC·20240109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K914910.

Data sourced from openFDA. This site is unofficial and independent of the FDA.