# K233346: Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable  (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable  (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable  (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable  (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable  (HMAL20/010);

- Pathway: 510(k) (Traditional)
- Applicant: Hg Innovations, Ltd.
- Decided: Nov 20, 2023 after 52 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: 6 generations back to K884656 (1988). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110924: Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps, Synergetics, Inc. (2011) Summary page 6.
- K193587: Sutter Swyng non-stick bipolar forceps, single-use, Sutter Medizintechnik GmbH (2020) Summary page 6.

## Indications for use
Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters: -Frequency range between 300 kHz-1,000 kHZ; -Maximum generator operating voltage 600Vp. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include: -ENT -Gynecology -Urology -General Surgery -Neurosurgery -Laryngeal Surgery -Orthopedic Surgery -Thoracic Surgery Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current. HG Innovations, as a manufacturer, does not recommend a specific procedure. Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small cross-sectional area of body.

Source page: https://510kreport.com/device/K233346
Methodology: https://510kreport.com/methodology