Ligasure Precise Model #LS1200/LIGASURE 5MM Laparoscopic Sealer Divider Model # LS1500
FDA 510(k) K041587 · Valleylab
510(k) numberK041587
Submission
- Device name
- Ligasure Precise Model #LS1200/LIGASURE 5MM Laparoscopic Sealer Divider Model # LS1500
- Applicant
- Valleylab
Boulder, CO, US - Received
- June 14, 2004
- Decision date
- September 28, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K043273 | Ligasure Vessel Sealing System. Ligasure InstrumentsGEI · Traditional | 01/05/2005SE |
| K042216 | Cool-Tip RF Ablation SystemGEI · Traditional | 11/12/2004SE |
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Questions and answers
When was Ligasure Precise Model #LS1200/LIGASURE 5MM Laparoscopic Sealer Divider Model # LS1500 cleared by the FDA?
Ligasure Precise Model #LS1200/LIGASURE 5MM Laparoscopic Sealer Divider Model # LS1500 (K041587) received a 510(k) decision of Substantially Equivalent on September 28, 2004, 106 days after the submission was received.
What is the product code of K041587?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.