T-Rx Retrieval Forceps
FDA 510(k) K970982 · Tri-Med Specialties, Inc.
510(k) numberK970982
Submission
- Device name
- T-Rx Retrieval Forceps
- Applicant
- Tri-Med Specialties, Inc.
Lenexa, KS, US - Received
- March 18, 1997
- Decision date
- May 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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.
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| K101298 | Endochoice Grasping Insulated and Aligator Jaw Forceps Model Amhgfa, Endochoice Grasping…OCZ · Traditional | Endochoice, Inc. | 08/05/2010SE |
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| K971615 | Pattison Esophageal DilatorKNQ · Traditional | 07/24/1997SE |
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| K942918 | Tri-Med Endoscopic Fluid Introduction CatheterOCX · Traditional | 02/28/1995SE |
| K950574 | Needle/CannulaLRO · Traditional | 02/24/1995SEKD |
| K934348 | Tri-Med Quick-Step Gastric Lavage Tube Sizes 18FR, 22FR, 32FRBSS · Traditional | 12/23/1994SE |
| K945160 | Paracentesis Needles/CannulasLRO · Traditional | 11/14/1994SE |
| K924549 | Tri-Med Quick-Step(Tm) Rectal TubeGBT · Traditional | 02/10/1994SE |
| K932015 | Tri-Med Inflatable Esophageal DilatorKNQ · Traditional | 02/03/1994SE |
| K932652 | Tri-Med Paracentesis TrayLRO · Traditional | 11/24/1993SEKD |
| K931201 | Tri-Med Endoscopic Fluid Introduction CatheterOCX · Traditional | 09/28/1993SE |
Questions and answers
When was T-Rx Retrieval Forceps cleared by the FDA?
T-Rx Retrieval Forceps (K970982) received a 510(k) decision of Substantially Equivalent on May 9, 1997, 52 days after the submission was received.
What is the product code of K970982?
The FDA product code is OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered, a Class II (moderate risk) device regulated under 21 CFR 876.1500.