Lamano Directors
FDA 510(k) K894592 · Marlo Surgical Technology
510(k) numberK894592
Submission
- Device name
- Lamano Directors
- Applicant
- Marlo Surgical Technology
Willoughby, OH, US - Received
- July 24, 1989
- Decision date
- September 8, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCM – Endoscope, Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GCM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203226 | Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL…GCM · Traditional | Richard Wolf Medical Instruments Corporation | 05/14/2021SE |
| K083840 | Msi Medserv International-Rigid EndoscopeGCM · Traditional | Msi Medserv International Deutschland GmbH | 09/28/2009SE |
| K001217 | Inside ViewGCM · Traditional | Monadnock Optics, Inc. | 07/11/2000SE |
| K993103 | ENDOSCOPES,10MM Diameter 0 Degrees; Endoscopes, 10MM Diameter, 30 Degrees; Endoscopes…GCM · Traditional | Richard Wolf Medical Instruments Corp. | 12/10/1999SE |
| K993445 | Omnisonic Endoscopic DeflectorGCM · Traditional | Omnisonics Medical Technologies | 12/06/1999SE |
| K962393 | Ksea Set for Endoscopic Assisted IntubationGCM · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/17/1996SE |
| K950712 | Portable Endoscopy SystemGCM · Traditional | Laser-Optik-Systeme GmbH & Co. KG | 05/14/1996SE |
| K955120 | Hand-Held Retractor, Dissector & DissectorGCM · Traditional | Ethicon Endo-Surgery, Inc. | 01/26/1996SE |
| K935235 | Endoscopy System for Facial Plastic SurgeryGCM · Traditional | Smith & Nephew Richards, Inc. | 03/23/1995SE |
| K945889 | Karl Storz Plastic Surgery AccessoriesGCM · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/22/1995SE |
More from KARL STORZ Endoscopy-America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960810 | Balloon Cannula 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X…HET · Traditional | 10/21/1996SE |
| K962273 | Malleable Stylet 18 CM ME1816ST, 23 CM ME1816NSTMFD · Traditional | 07/31/1996SE |
| K924611 | Irrigation Pump and Tubing SetHET · Traditional | 06/30/1994SE |
| K932832 | Primus Insulated ForcepsHET · Traditional | 02/25/1994SE |
| K932634 | Nu-Tip(Tm) Forceps:Graspers/Dissectors/SuturesHET · Traditional | 02/25/1994SE |
| K920611 | Marlow Laparoscopic Grasping ForcepGCJ · Traditional | 04/20/1993SE |
| K914153 | Ott Insufflator Filter Plus/Tubing SetHIF · Traditional | 04/02/1992SE |
| K914869 | Marlow Laparoscopic ScissorsGCJ · Traditional | 01/15/1992SE |
| K913954 | Marlow/Reddick Laparoscopic Needle HoldersGCJ · Traditional | 12/18/1991SE |
| K914872 | Marlow Suction/Irrigation ProbesGSJ · Traditional | 11/19/1991SE |
Questions and answers
When was Lamano Directors cleared by the FDA?
Lamano Directors (K894592) received a 510(k) decision of Substantially Equivalent on September 8, 1989, 46 days after the submission was received.
What is the product code of K894592?
The FDA product code is GCM – Endoscope, Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.