Ott Insufflator Filter Plus/Tubing Set
FDA 510(k) K914153 · Marlo Surgical Technology
510(k) numberK914153
Submission
- Device name
- Ott Insufflator Filter Plus/Tubing Set
- Applicant
- Marlo Surgical Technology
Willoughby, OH, US - Received
- September 16, 1991
- Decision date
- April 2, 1992
- 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 |
|---|---|---|
| K960810 | Balloon Cannula 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X…HET · Traditional | 10/21/1996SE |
| K962273 | Malleable Stylet 18 CM ME1816ST, 23 CM ME1816NSTMFD · Traditional | 07/31/1996SE |
| K924611 | Irrigation Pump and Tubing SetHET · Traditional | 06/30/1994SE |
| K932832 | Primus Insulated ForcepsHET · Traditional | 02/25/1994SE |
| K932634 | Nu-Tip(Tm) Forceps:Graspers/Dissectors/SuturesHET · Traditional | 02/25/1994SE |
| K920611 | Marlow Laparoscopic Grasping ForcepGCJ · Traditional | 04/20/1993SE |
| K914869 | Marlow Laparoscopic ScissorsGCJ · Traditional | 01/15/1992SE |
| K913954 | Marlow/Reddick Laparoscopic Needle HoldersGCJ · Traditional | 12/18/1991SE |
| K914872 | Marlow Suction/Irrigation ProbesGSJ · Traditional | 11/19/1991SE |
| K913964 | Marlow/Reddick Laparoscopic Grasping ForcepsHTD · Traditional | 10/23/1991SE |
Questions and answers
When was Ott Insufflator Filter Plus/Tubing Set cleared by the FDA?
Ott Insufflator Filter Plus/Tubing Set (K914153) received a 510(k) decision of Substantially Equivalent on April 2, 1992, 199 days after the submission was received.
What is the product code of K914153?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.