Insufflation Needle, Model R65-933
FDA 510(k) K000027 · A & A Medical, Inc.
510(k) numberK000027
Submission
- Device name
- Insufflation Needle, Model R65-933
- Applicant
- A & A Medical, Inc.
Alpharetta, GA, US - Received
- January 5, 2000
- Decision date
- April 3, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K013491 | HSG Catheter Set, 5F Model RGS0947, HSG Catheter Set, 7F, Model R65-948LKF · Traditional | 11/19/2001SE |
| K013437 | SF SH Catheter, Model R65-945LKF · Traditional | 11/19/2001SE |
| K003949 | Tacker, Model R65-933OCW · Traditional | 07/25/2001SE |
| K011512 | Mmodification to LaminariaHDY · Traditional | 07/09/2001SE |
| K010510 | Balloon Cannula, Short, Model R65-985; Balloon Cannula, Long, Model R65-985-1HET · Traditional | 05/16/2001SE |
| K010789 | Cannula, Surgical General & Plastic Surgery, MODELR65-995, R65-995-1, R65-995-2…GCJ · Traditional | 04/27/2001SE |
| K010056 | Uterine Manipulator Injector Cannula, Sterile, Model R 57-450LKF · Traditional | 02/01/2001SE |
| K994256 | Suction Irrigation Trumpet Valve Set, Model Q65-823GCJ · Traditional | 02/03/2000SE |
| K974038 | The Aspirator, 6FT Silicone Tubing, Metal Tubing Adapter, Glass Reservoir, Neoprene…JCX · Traditional | 05/11/1998SE |
| K974138 | Rocket ElectrodeHGI · Traditional | 01/30/1998SE |
Questions and answers
When was Insufflation Needle, Model R65-933 cleared by the FDA?
Insufflation Needle, Model R65-933 (K000027) received a 510(k) decision of Substantially Equivalent on April 3, 2000, 89 days after the submission was received.
What is the product code of K000027?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.