Re-New Forceps Laparoscopic Surgical Tips
FDA 510(k) K974066 · Microline Pentax, Inc.
510(k) numberK974066
Submission
- Device name
- Re-New Forceps Laparoscopic Surgical Tips
- Applicant
- Microline Pentax, Inc.
Beverly, MA, US - Received
- October 27, 1997
- Decision date
- January 22, 1998
- 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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| K962119 | Re-New Laparoscopic InstrumentsGEI · Traditional | 08/09/1996SE |
| K932648 | Quick Switch Laparoscopic InstrumentsGCJ · Traditional | 10/12/1993SE |
| K897093 | Intraocular Microscissors by Means of Gamma Radia.HNF · Traditional | 04/04/1990SE |
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Questions and answers
When was Re-New Forceps Laparoscopic Surgical Tips cleared by the FDA?
Re-New Forceps Laparoscopic Surgical Tips (K974066) received a 510(k) decision of Substantially Equivalent on January 22, 1998, 87 days after the submission was received.
What is the product code of K974066?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.