Visitec Precise-Point
FDA 510(k) K942234 · Visitec Co.
510(k) numberK942234
Submission
- Device name
- Visitec Precise-Point
- Applicant
- Visitec Co.
Sarasota, FL, US - Received
- May 9, 1994
- Decision date
- July 12, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAP – Suture, Nonabsorbable, Silk
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5030
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241486 | Sofsilk Coated Braided Silk SutureGAP · Traditional | Covidien | 12/03/2024SE |
| K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…GAP · Traditional | Safepath Medical, Inc. | 10/18/2024SE |
| K232355 | Non absorbable Surgical Silk SutureGAP · Traditional | Shandong Haidike Medical Product Co., Ltd. | 01/16/2024SE |
| K221767 | Surgical Sutures with or without NeedleGAP · Traditional | Huaian Seamen Medical Technology Co., Ltd. | 07/31/2023SE |
| K180701 | SafePath Suturing SystemGAP · Traditional | Safepath Medical, Inc. | 06/25/2018SE |
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Special | M/s. Meril Endo Surgery Private Limited. | 10/20/2017SE |
| K162396 | SILK Surgical SutureGAP · Traditional | Teleflexmedical, Inc. | 11/23/2016SE |
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Traditional | M/s. Meril Endo Surgery Private Limited. | 05/31/2016SE |
| K080684 | Wg-Surgical Sutures with NeedleGAP · Traditional | Foosin Medical Supplies, Inc. | 06/09/2008SE |
| K071111 | Non-Absorbable Silk SutureGAP · Traditional | Arrow Intl., Inc. | 07/17/2007SE |
More from Arrow Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953394 | Visitec Collar Button Catheter {Griffiths}LZU · Traditional | 10/12/1995SE |
| K945114 | Visitec Scleral PlugLXP · Traditional | 02/23/1995SE |
| K945738 | Visiflex Ophthalmic Surgical Incise DrapeHMT · Traditional | 02/14/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | 01/17/1995SE |
| K934269 | Fiberoptic Illuminated InstrumentsHJM · Traditional | 05/17/1994SE |
| K940210 | Visitec Eye PadEFQ · Traditional | 03/07/1994SE |
| K933872 | Visi-Spear Eye SpongeHOZ · Traditional | 12/27/1993SE |
| K923972 | Ophthalmic Fluid Distribution SetsFPK · Traditional | 11/04/1992SE |
| K922530 | Visitec Microsurgical SutureGAR · Traditional | 10/20/1992SE |
| K923645 | Visitec Aspirating SyringeFMF · Traditional | 09/30/1992SE |
Questions and answers
When was Visitec Precise-Point cleared by the FDA?
Visitec Precise-Point (K942234) received a 510(k) decision of Substantially Equivalent on July 12, 1994, 64 days after the submission was received.
What is the product code of K942234?
The FDA product code is GAP – Suture, Nonabsorbable, Silk, a Class II (moderate risk) device regulated under 21 CFR 878.5030.