# K973648: Mini Forceps with HF, 3.5MM; Micro Forceps with HF, 2MM

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Dec 17, 1997 after 83 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935070 (1994). 2 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935270: Modular Forcep and Scissor System, Richard Wolf Medical Instruments Corp. (1994) Summary page 1.
- K935070: Grasping Forceps, Biopsy Forceps, Spoon Forceps, KARL STORZ Endoscopy-America, Inc. (1994) Summary page 1.
- (no number) pre-enactment forceps/scissors with H.F. 8383.03, .12, 930L, 930S: named in the summary without a submission number
- (no number) Biopsy Instruments, Endoscopic Instrumentation 3.5/5 mm: named in the summary without a submission number

## Most influential descendants
- K980758: 3 MM Selec-Tip Laparoscopic Scissors (1998), 10 descendants of its own
- K014207: Reposable Instrument System, Models MF001-MF083 (2002), 8 descendants of its own
- K063485: Logic Laparoscopic Scissors (2006), 7 descendants of its own
- K090583: Endoscopic Monopolar Scissors, Models Ems-235, Ems-165 (2009), 4 descendants of its own
- K141058: Ensizor Endoscopic Scissors (2014), 3 descendants of its own

## Indications for use
The forceps are used for grasping, manipulating and cutting as well as the dissection and biopsy of soft tissue/ organs under endoscopic control. The modular scissors can also be used for cutting of suture material. Minor hemorrhages can be coagulated using HF current, provided that products are marked accordingly. The modular forceps can be disassembled for easy cleaning and replacement. For examination, diagnostics and/or therapy by qualified, suitably trained personnel in connection with endoscopically used accessories in different medical disciplines, such as surgery, urology and gynecology, particularly suitable for outpatient and pediatric laparoscopy.

Source page: https://510kreport.com/device/K973648
Methodology: https://510kreport.com/methodology