Product code FDC
- Device name
- Resectoscope, Working Element
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021166 | ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR | Acmi-Circon Corporation | 2002-05-09 |
| K992141 | OLYMPUS WORKING ELEMENT FOR PROBES | Olympus Winter & Ibe GmbH | 1999-09-29 |
| K991426 | MAHE INSTRUMENTS | Mahe Intl., Inc. | 1999-08-05 |
| K942626 | CONTINUOUS FLOW BIOPSY PROBE | Gm Engineering, Inc. | 1995-05-30 |
| K933962 | GM CONTINUOUS FLOW BIOPSY PROBE | Gm Engineering, Inc. | 1994-02-25 |
| K895643 | MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM | Orthoconcept, Inc. | 1989-10-17 |
| K894363 | UROPUMP* FLUID MANAGEMENT SYSTEM | Orthoconcept, Inc. | 1989-08-11 |
| K842997 | LASER RECTOSCOPE SET 784 | Laser Industries , Ltd. | 1984-08-27 |
| K760182 | SHEATH, RESECTOSCOPE | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
| K760184 | ELEMENT, WORKING | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
| K760174 | ADAPTER, RESECTOSCOPE | V. Mueller O.V. Baxter Healthcare Corp. | 1976-08-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03665415002895 | Active working element UNIV extra length (SIDE LOAD; round; Fr 26; STORZ compati | LAMIDEY NOURY MEDICAL | 2025-10-08 |
| 03665415002888 | Passive working element UNIV extra length (SIDE LOAD; round; Fr 26; STORZ compat | LAMIDEY NOURY MEDICAL | 2025-10-08 |
| 03665415002857 | Passive working element (SIDE load; round ; Fr26 ; WOLF compatible) | LAMIDEY NOURY MEDICAL | 2025-10-08 |
| 03665415002840 | Active working element (SIDE load; round ; Fr26 ; WOLF compatible) | LAMIDEY NOURY MEDICAL | 2025-10-08 |
| 03665415002802 | Passive working element (SIDE load; round ; Fr22 ; STORZ compatible) | LAMIDEY NOURY MEDICAL | 2025-04-24 |
| 03665415002796 | Active working element (SIDE load; round ; Fr22 ; STORZ compatible) | LAMIDEY NOURY MEDICAL | 2025-04-24 |
| 03665415002772 | Bipolar cutting loop / SLIM (round; Fr22) | LAMIDEY NOURY MEDICAL | 2025-04-24 |
| 03665415002161 | Passive working element (SIDE load; round ; Fr26 ; OLYMPUS compatible) | LAMIDEY NOURY MEDICAL | 2023-04-21 |
| 03665415002154 | Active working element (SIDE load; round ; Fr26 ; OLYMPUS compatible) | LAMIDEY NOURY MEDICAL | 2023-04-21 |
| 03665415002413 | Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26) | LAMIDEY NOURY MEDICAL | 2023-04-21 |
| 03665415002291 | Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26) | LAMIDEY NOURY MEDICAL | 2023-04-21 |
| 03665415002277 | Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26) | LAMIDEY NOURY MEDICAL | 2023-04-21 |
| 03665415002253 | Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26) | LAMIDEY NOURY MEDICAL | 2023-04-21 |
| 03665415002185 | Passive working element (SIDE load; round ; Fr26 ; STORZ compatible) | LAMIDEY NOURY MEDICAL | 2023-04-21 |
| 03665415002178 | Active working element (SIDE load; round ; Fr26 ; STORZ compatible) | LAMIDEY NOURY MEDICAL | 2023-04-21 |
| 03760263240052 | Front load bipolar electrode | CHIRURGIE INNOVATION | 2019-10-09 |
| 03760263240182 | Working element for FRONT load bipolar electrode | CHIRURGIE INNOVATION | 2019-10-09 |
| 03760263240175 | Working element for FRONT load bipolar electrode | CHIRURGIE INNOVATION | 2019-10-09 |
| 03760263240168 | Working element for FRONT load bipolar electrode | CHIRURGIE INNOVATION | 2019-10-09 |
| 03760263240151 | Working element for FRONT load bipolar electrode | CHIRURGIE INNOVATION | 2019-10-09 |
| 03760263240144 | Working element for FRONT load bipolar electrode | CHIRURGIE INNOVATION | 2019-10-09 |
| 03760263240137 | Working element for FRONT load bipolar electrode | CHIRURGIE INNOVATION | 2019-10-09 |
| 03760263240113 | Working element for SIDE load bipolar electrode | CHIRURGIE INNOVATION | 2019-10-09 |
| 03760263240106 | Working element for SIDE load bipolar electrode | CHIRURGIE INNOVATION | 2019-10-09 |
| 03760263240090 | Working element for SIDE load bipolar electrode | CHIRURGIE INNOVATION | 2019-10-09 |
| 04042761004442 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-22 |
| 04042761021104 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761021210 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761029483 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761030281 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |