The Tulip Insulated Graspers
FDA 510(k) K952957 · The Tulip Mfg. Co.
510(k) numberK952957
Submission
- Device name
- The Tulip Insulated Graspers
- Applicant
- The Tulip Mfg. Co.
Mesa, AZ, US - Received
- June 26, 1995
- Decision date
- October 30, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K260884 | UNIDRIVE Select SystemGCJ · Traditional | Karl Storz SE & CO. KG | 09/01/2026SE |
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| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
| K261614 | LED LCD Monitor (OEV-271H)GCJ · Traditional | Lg Electronics.Inc | 07/17/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K952959 | The Tulip Laparoscope Sheath 6MM Dual StopcockGCJ · Traditional | 01/22/1996SE |
| K952906 | The Tulip Laparoscope Sheath 6MM Single StopcockGCJ · Traditional | 01/22/1996SE |
| K955502 | The Tulip Mono Polar Rotatable Metz ScissorsGEI · Traditional | 01/17/1996SE |
| K955501 | The Tulip Mono Polar Rotatable Alligator ForcepGEI · Traditional | 01/17/1996SE |
| K954734 | The Tulip LCI-200 Illumination & Imaging System (Modification)FET · Traditional | 11/14/1995SE |
| K952958 | The Tulip Company Branson OversheathGCJ · Traditional | 11/14/1995SE |
| K952953 | The Tulip Cxompany Branson #2 ElevatorGCJ · Traditional | 11/14/1995SE |
| K952951 | The Tulip Company Brason Nerve Hook & DissectorGCJ · Traditional | 11/14/1995SE |
| K952932 | The Tulip Company Branson #1 ElevatorGCJ · Traditional | 11/14/1995SE |
| K952902 | The Tulip Company Branson Posterior DissectorGCJ · Traditional | 11/14/1995SE |
Questions and answers
When was The Tulip Insulated Graspers cleared by the FDA?
The Tulip Insulated Graspers (K952957) received a 510(k) decision of Substantially Equivalent on October 30, 1995, 126 days after the submission was received.
What is the product code of K952957?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.