Ethicon Endo Surgery Slotted Anoscope
FDA 510(k) K093896 · Ethicon Endo-Surgery, Inc.
510(k) numberK093896
Submission
- Device name
- Ethicon Endo Surgery Slotted Anoscope
- Applicant
- Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US - Received
- December 18, 2009
- Decision date
- March 25, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FER – Anoscope And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine and perform procedures within the anus and rectum.
Other 510(k)s with product code FER
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)FER · Traditional | Haemoband Surgical, Ltd. | 10/09/2025SE |
| K242668 | Gastro Concepts Air AssistFER · Traditional | Gastro Concepts, LLC | 12/13/2024SE |
| K230439 | WellCare AnoscopeFER · Traditional | Well Care (Wuhan) Medical Technology Co., Ltd. | 12/22/2023SE |
| K200021 | Applied Medical AnoscopeFER · Traditional | Applied Medical Resources | 01/06/2021SE |
| K171701 | GelPOINT Path Transanal Access PlatformFER · Traditional | Applied Medical Resources Corp. | 07/20/2017SE |
| K133393 | Gelpoint Path Transanal Access PlatformFER · Traditional | Applied Medical Resources Corp. | 01/02/2014SE |
| K133687 | THD N-Ano AnoscopeFER · Special | Thd Spa | 12/11/2013SE |
| K121604 | Anospec Disposable Ansoscope with LightFER · Traditional | Obp Corporation | 07/27/2012SE |
| K121135 | THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeFER · Traditional | Thd Spa | 06/01/2012SE |
| K110792 | Gelpoint PathFER · Traditional | Applied Medical Resources Corp. | 05/23/2011SE |
More from Applied Medical Resources Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON…GDW · Traditional | 05/11/2026SE |
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)OXC · Traditional | 01/09/2026SE |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler…GDW · Traditional | 12/17/2025SE |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional | 05/14/2025SE |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler…GDW · Traditional | 02/25/2025SE |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional | 10/28/2024SE |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S)…GAG · Special | 07/03/2024SE |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic…FZP · Special | 08/29/2023SE |
| K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue…GEI · Traditional | 04/13/2023SE |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR…GDW · Traditional | 03/15/2023SE |
Questions and answers
When was Ethicon Endo Surgery Slotted Anoscope cleared by the FDA?
Ethicon Endo Surgery Slotted Anoscope (K093896) received a 510(k) decision of Substantially Equivalent on March 25, 2010, 97 days after the submission was received.
What is the product code of K093896?
The FDA product code is FER – Anoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.