Grasp Forceps/Scissors/Needle Holder/Dissector
FDA 510(k) K931340 · Baxter Healthcare Corp
510(k) numberK931340
Submission
- Device name
- Grasp Forceps/Scissors/Needle Holder/Dissector
- Applicant
- Baxter Healthcare Corp
Niles, IL, US - Received
- March 16, 1993
- Decision date
- July 1, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCS – Endoscope, Battery-Powered And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
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| K933201 | Aesculap Trocar Instrument SetGCS · Traditional | Aesculap, Inc. | 09/13/1993SE |
| K932762 | 10.0MM Suction/Irrigation Probe & Tubing KitGCS · Traditional | Inman Medical Corp. | 08/31/1993SE |
| K933371 | Imc Endoscopic Instrument HolderGCS · Traditional | Inman Medical Corp. | 08/06/1993SE |
| K924134 | Leisegang Laparoscopic Irrigation System/AccessGCS · Traditional | Leisegang Medical, Inc. | 07/02/1993SE |
| K925276 | M.I.S. Trocar-CannulaGCS · Traditional | M.I.S. Technology, Inc. | 05/24/1993SE |
| K921006 | Laparoscopic Retractor SystemGCS · Traditional | Laparomed Corp. | 07/28/1992SE |
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Questions and answers
When was Grasp Forceps/Scissors/Needle Holder/Dissector cleared by the FDA?
Grasp Forceps/Scissors/Needle Holder/Dissector (K931340) received a 510(k) decision of Substantially Equivalent on July 1, 1993, 107 days after the submission was received.
What is the product code of K931340?
The FDA product code is GCS – Endoscope, Battery-Powered And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.