DISPOSABLE RE-NEW FORCEPS— 510(k) K981389

Name: FDA 510(k) clearance K981389
Creator: U.S. Food and Drug Administration
Published: 1998-05-29

Substantially Equivalent

Microline Pentax, Inc.

FDA 510(k) clearance K981389 for DISPOSABLE RE-NEW FORCEPS, Substantially Equivalent on 1998-05-29. Applicant: Microline Pentax, Inc.. Device class: 2.

Clearance details

Applicant: Microline Pentax, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1998-04-16
Decision date: 1998-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley, MA, US

Download summary PDF View on FDA.gov ↗

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K013695 — MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-102002-01-08
K982984 — ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS1998-10-21
K981188 — ELECTROSURGICAL CAUTERY PROBES1998-05-20
K980758 — 3 MM SELEC-TIP LAPAROSCOPIC SCISSORS1998-03-27
K974066 — RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS1998-01-22

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 K981389

K-number listed on FDA's recall record

Z-1740-2018 — ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.Class II·Terminated·Microline Surgical, Inc.·20171101
Z-1986-2014 — Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221Class II·Terminated·Microline Surgical, Inc.·20140512
Z-1987-2014 — Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222Class II·Terminated·Microline Surgical, Inc.·20140512
Z-1635-2014 — Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.Class II·Terminated·Microline Surgical·20140414

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981389.

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