Medicam 900 Insufflator with Accessories
FDA 510(k) K921837 · Kirschner Medical Corp.
510(k) numberK921837
Submission
- Device name
- Medicam 900 Insufflator with Accessories
- Applicant
- Kirschner Medical Corp.
Timonium, MD, US - Received
- April 17, 1992
- Decision date
- February 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HIF – Insufflator, Laparoscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1730
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260209 | ENDOFLATOR+; Smart Smoke EvacuationHIF · Traditional | Karl Storz SE & CO. KG | 08/19/2026SE |
| K252584 | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)HIF · Traditional | Weyo Surgical Technology , Ltd. | 06/25/2026SE |
| K252318 | Insufflator (OPTO-IFL1000)HIF · Traditional | Guangdong Optomedic Technologies, Inc. | 04/16/2026SE |
| K250388 | Endoflator +HIF · Traditional | Karl Storz SE & CO. KG | 09/22/2025SE |
| K242772 | AirSurgN Insufflator (10030/AirSurgN)HIF · Traditional | SmartsurgN, Inc. | 04/11/2025SE |
| K243527 | High Flow Insufflation Unit (UHI-4)HIF · Traditional | Olympus Medical Systems Corporation | 01/13/2025SE |
| K242536 | TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional | Tautona Group | 10/15/2024SE |
| K232902 | EVA15 insufflatorHIF · Traditional | Palliare , Ltd. | 05/02/2024SE |
| K232464 | VereSee Optical Veres Needle SystemHIF · Traditional | Freyja Healthcare, LLC | 05/02/2024SE |
| K233020 | TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional | Tautona Group Research & Development, Co., LLC | 01/12/2024SE |
More from Tautona Group Research & Development, Co., LLC
| 510(k) | Device | Decision |
|---|---|---|
| K940537 | Kirschner(R) Modular Ii-C(Tm) Total Shoulder SystemKWT · Traditional | 08/29/1995SE |
| K936274 | Kirschner Performance Posterior Stabilized Total Knee SystemJWH · Traditional | 01/18/1995SE |
| K942891 | Summit Total Hip SystemMEH · Traditional | 11/02/1994SE |
| K941486 | Integrity Total Hip System, Non-PorousJDI · Traditional | 09/20/1994SE |
| K933843 | Line Extension for Kirschner Performance Total Knee System, Porous CoatedJWH · Traditional | 08/05/1994SE |
| K935951 | Kirschner C-2 Osteocap Total Hip SystemJDI · Traditional | 07/18/1994SE |
| K935206 | Kirschner Integrity Acetabular Cup ModificationJDI · Traditional | 07/13/1994SE |
| K934589 | Kirschner Performance Total Knee System Porous CoatedJWH · Traditional | 07/13/1994SN |
| K934694 | Kirschner Zirconia Femoral HeadLZO · Traditional | 05/18/1994SE |
| K920188 | Threaded PinsMBJ · Traditional | 05/12/1993SE |
Questions and answers
When was Medicam 900 Insufflator with Accessories cleared by the FDA?
Medicam 900 Insufflator with Accessories (K921837) received a 510(k) decision of Substantially Equivalent on February 5, 1993, 294 days after the submission was received.
What is the product code of K921837?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.