Blade, Scalpel & Blade, Handel
FDA 510(k) K954536 · Access Surgical Intl., Inc.
510(k) numberK954536
Submission
- Device name
- Blade, Scalpel & Blade, Handel
- Applicant
- Access Surgical Intl., Inc.
Plymouth, MA, US - Received
- September 29, 1995
- Decision date
- November 29, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
Other 510(k)s with product code OCZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252800 | KARL STORZ Endoscopic Accessories for UrologyOCZ · Traditional | Karl Storz SE & CO. KG | 06/03/2026SE |
| K242923 | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter…OCZ · Traditional | Envision Endoscopy | 12/20/2024SE |
| K191900 | Single Use Grasping ForcepsOCZ · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 03/27/2020SE |
| K152802 | Grasping ForcepsOCZ · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 01/21/2016SE |
| K150939 | Ensizor Endoscopic ScissorsOCZ · Traditional | Slater Endoscopy, LLC | 06/08/2015SE |
| K141058 | Ensizor Endoscopic ScissorsOCZ · Traditional | Slater Endoscopy, LLC | 08/01/2014SE |
| K133736 | Endoscopic Suture CutterOCZ · Traditional | United States Endoscopy Group, Inc. | 01/07/2014SE |
| K120084 | Endoscopic Retrieval DeviceOCZ · Traditional | United States Endoscopy Group, Inc. | 05/30/2012SE |
| K103688 | G-Prox Ez Endoscopic GrasperOCZ · Special | Usgi Medical | 01/14/2011SE |
| K101298 | Endochoice Grasping Insulated and Aligator Jaw Forceps Model Amhgfa, Endochoice Grasping…OCZ · Traditional | Endochoice, Inc. | 08/05/2010SE |
More from Endochoice, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953376 | Access PointGCJ · Traditional | 09/12/1995SE |
| K945545 | Access Surgical Int'L Thoracic Endoscopic Surgical InstrumentsGCJ · Traditional | 01/12/1995SE |
| K944974 | Access PointGCJ · Traditional | 11/08/1994SE |
| K940587 | Flex-I-PortGCJ · Traditional | 03/29/1994SE |
| K933192 | Access Surgical Int'L Inc. Endoscopic Surg. Inst.GCJ · Traditional | 11/18/1993SE |
| K922424 | Access Surgical Int'L Endoscopic Surgical Instrum.GCJ · Traditional | 11/25/1992SE |
| K922423 | Access Surgical Bipolar Endoscopic Surg. Instrum.GEI · Traditional | 11/18/1992SE |
| K922425 | Access Surgical Monopolar Endoscopic Surg. InstrumGEI · Traditional | 11/17/1992SE |
Questions and answers
When was Blade, Scalpel & Blade, Handel cleared by the FDA?
Blade, Scalpel & Blade, Handel (K954536) received a 510(k) decision of Substantially Equivalent on November 29, 1995, 61 days after the submission was received.
What is the product code of K954536?
The FDA product code is OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered, a Class II (moderate risk) device regulated under 21 CFR 876.1500.