Imc Endoscopic Instrument Holder
FDA 510(k) K933371 · Inman Medical Corp.
510(k) numberK933371
Submission
- Device name
- Imc Endoscopic Instrument Holder
- Applicant
- Inman Medical Corp.
Fort Worth, TX, US - Received
- July 9, 1993
- Decision date
- August 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code GCS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944062 | Laprascopic GrasperGCS · Traditional | Instrument Makar, Inc. | 02/23/1995SE |
| K944067 | Peanut Wand, ModificationGCS · Traditional | Ideal Medical, Inc. | 12/08/1994SE |
| 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 |
| 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 |
More from Laparomed Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K933171 | Inman Irrigation Tapered ProbeKYZ · Traditional | 04/29/1994SE |
| K933169 | Inman Endoscopic Blunt DissectorGCJ · Traditional | 04/19/1994SE |
| K933094 | Insufflator Tubing Kit W/FilterHIF · Traditional | 04/18/1994SE |
| K933382 | Imc Cable/Wire CoverKKX · Traditional | 01/27/1994SE |
| K933774 | Imc Saline Wet DressingFRO · Traditional | 11/08/1993SN |
| K933306 | Imc 5.0MM Irrigation/Aspiration Probe W/HolesGCY · Traditional | 10/05/1993SE |
| K933305 | Imc 5.0MM Irrigation/Aspiration ProbeGCY · Traditional | 10/05/1993SE |
| K933170 | Inman Poole Tip Suction Probe W/Tubing KitGCY · Traditional | 09/16/1993SE |
| K932762 | 10.0MM Suction/Irrigation Probe & Tubing KitGCS · Traditional | 08/31/1993SE |
| K921291 | Inman Medical Packing StripFER · Traditional | 01/21/1993SE |
Questions and answers
When was Imc Endoscopic Instrument Holder cleared by the FDA?
Imc Endoscopic Instrument Holder (K933371) received a 510(k) decision of Substantially Equivalent on August 6, 1993, 28 days after the submission was received.
What is the product code of K933371?
The FDA product code is GCS – Endoscope, Battery-Powered And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.