Laprascopic Grasper
FDA 510(k) K944062 · Instrument Makar, Inc.
510(k) numberK944062
Submission
- Device name
- Laprascopic Grasper
- Applicant
- Instrument Makar, Inc.
Okemos, MI, US - Received
- August 19, 1994
- Decision date
- February 23, 1995
- 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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|---|---|---|---|
| K944067 | Peanut Wand, ModificationGCS · Traditional | Ideal Medical, Inc. | 12/08/1994SE |
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| 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 |
| K931340 | Grasp Forceps/Scissors/Needle Holder/DissectorGCS · Traditional | Baxter Healthcare Corp | 07/01/1993SE |
| 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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| K943249 | Bioabsorbable Interference ScrewMAI · Traditional | 07/31/1995SE |
| K942828 | Makar Full and Half Face ShieldLYU · Traditional | 02/23/1995SE |
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Questions and answers
When was Laprascopic Grasper cleared by the FDA?
Laprascopic Grasper (K944062) received a 510(k) decision of Substantially Equivalent on February 23, 1995, 188 days after the submission was received.
What is the product code of K944062?
The FDA product code is GCS – Endoscope, Battery-Powered And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.