# K981389: Disposable RE-New Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Microline Pentax, Inc.
- Decided: May 29, 1998 after 43 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K932648 (1993). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974066: RE-New Forceps Laparoscopic Surgical Tips, Microline Pentax, Inc. (1998) Summary page 1.

## Most influential descendants
- K071976: Vectec Disposable Trocars and Laparoscopic Accessories (2007), 3 descendants of its own
- K101937: Hybrid Trocar System (2010), 1 descendant of its own
- K153126: da Vinci Xi Hasson Cone (2015), 0 descendants of its own
- K081398: Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories (2009), 0 descendants of its own

## Recalls of this device
- Nov 1, 2017 · Class II · Z-1740-2018: Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
- May 12, 2014 · Class II · Z-1987-2014: Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
- May 12, 2014 · Class II · Z-1986-2014: Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
- Apr 14, 2014 · Class II · Z-1635-2014: Grasper jaw may break when force is applied to the jaw
- Jul 18, 2011 · Not classified · Z-3086-2011: Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled as product number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestra
- Jul 18, 2011 · Not classified · Z-3085-2011: Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled as product number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestra

## Indications for use
Cutting, Grasping, and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures.

Source page: https://510kreport.com/device/K981389
Methodology: https://510kreport.com/methodology