Sharpe Endotenaculum
FDA 510(k) K915743 · Paladin Medical, Inc.
510(k) numberK915743
Submission
- Device name
- Sharpe Endotenaculum
- Applicant
- Paladin Medical, Inc.
Stillwater, MN, US - Received
- December 23, 1991
- Decision date
- May 20, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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More from 270surgical , Ltd.
| 510(k) | Device | Decision |
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| K993306 | Nikopad Electrosurgical Grounding Pad (*Or Sold Under Commercial Names), Model 4760…HAM · Special | 11/03/1999SE |
| K970347 | MPC (Model 7000) External Temporary Pacemaker SystemDTE · Traditional | 08/29/1997SE |
| K971290 | Stratasys FDM Medmodeler SystemLLZ · Traditional | 06/20/1997SE |
| K964222 | Acu-Clens Cleaning System for Contact Lens CleaningLYL · Traditional | 12/20/1996SE |
| K950054 | Endo-Bend(Tm) ShaverHRX · Traditional | 06/29/1995SE |
| K935220 | Core Prevent Mattress ModificationFMW · Traditional | 11/29/1993SE |
| K921015 | Sharpe Endosponge AspiiratorHET · Traditional | 05/21/1993SE |
| K921888 | Sharpe EndodissectorHET · Traditional | 10/20/1992SE |
| K915749 | Sharpe Endoligature CarrierHET · Traditional | 10/20/1992SE |
| K915747 | Sharpe EndoforcepsHET · Traditional | 10/20/1992SE |
Questions and answers
When was Sharpe Endotenaculum cleared by the FDA?
Sharpe Endotenaculum (K915743) received a 510(k) decision of Substantially Equivalent on May 20, 1993, 514 days after the submission was received.
What is the product code of K915743?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.