510(k) K864402 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE
| Applicant | New England Surgical Instrument Corp., Rockland MA, US |
| Decision | Substantially Equivalent, Jan 20, 1987 |
| Received | Nov 6, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864402
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2024 | Kirwan Surgical Products, LLC Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other sof Open, Classified |
GEI | None listed |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and ot Open, Classified |
GEI | None listed |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and o Open, Classified |
GEI | None listed |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226.
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For Open, Classified |
GEI | None listed |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011.
Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue Open, Classified |
GEI | None listed |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979.
Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and othe Open, Classified |
GEI | None listed |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011.
Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.