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);
FDA 510(k) clearance K233346 · decided 2023-11-20
Clearance details
- K-number
- K233346
- Device name
- 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);
- Applicant
- Hg Innovations, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-29
- Decision date
- 2023-11-20
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lancashire, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.