# K981321: Bipolar Forceps Set (Modular)

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Jul 7, 1998 after 88 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kleppinger bipolar forceps 8383.21, 8384.21: named in the summary without a submission number

## Most influential descendants
- K990147: Bipolar Forceps, Kleppinger Insert, Model #'S 8393.741,8393.771,8394.741,8394.771 (1999), 0 descendants of its own

## Indications for use
For the coagulation of tubes, tissue coagulation and vascular coagulation to stop bleedings under endoscopic vision. For therapy in connection with endoscopic accessories used in medical specialties such as urology, gynecology. surgery. Not 10 be used for female sterilization (coagulation of fallopian tbes). Contraindications are inflammations or bacterial contamination of wounds in the operation site. Contraindications directly related to the product are currently unknown. The attending physician must determine if the intended use is appropriate based on the general condition of the patient. For further instructions, refer to the latest medical literature.

Source page: https://510kreport.com/device/K981321
Methodology: https://510kreport.com/methodology