ORS-100
FDA 510(k) K921568 · Mnlase, Inc.
510(k) numberK921568
Submission
- Device name
- ORS-100
- Applicant
- Mnlase, Inc.
Reston, VA, US - Received
- April 2, 1992
- Decision date
- June 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JRM – Freezer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JRM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921570 | ORS-300JRM · Traditional | Mnlase, Inc. | 06/09/1992SE |
| K921569 | ORS-200JRM · Traditional | Mnlase, Inc. | 06/09/1992SE |
| K915427 | ORS-1000JRM · Traditional | Mnlase, Inc. | 01/07/1992SE |
| K913777 | Self-Contained Surgical Slush FreezerJRM · Traditional | Taylor Corp. | 09/25/1991SE |
| K894006 | Saniserv Surgical Slush SystemJRM · Traditional | Saniserv, Inc. | 11/03/1989SE |
| K782077 | Lancer Ice CubeJRM · Traditional | Sherwood Medical Industries | 04/03/1979SE |
More from Sherwood Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K944630 | Model 230-SAS Laser Delivery ProbeGEX · Traditional | 11/09/1994SE |
| K944629 | Model 230-SAC Laser Delivery ProbeGEX · Traditional | 11/03/1994SE |
| K944628 | Model 220-SS Laser Delivery ProbeGEX · Traditional | 11/03/1994SE |
| K944627 | Model 220-SC Curved Endophotocoagulator LaserGEX · Traditional | 11/03/1994SE |
| K944626 | Model 210-AS Aspirating Endophotocoagulator LaserGEX · Traditional | 11/03/1994SE |
| K944625 | Model 210-AC Aspirating Endophotocoagulator LaserGEX · Traditional | 11/03/1994SE |
| K944471 | Straight Endophotocoagulator Laser ProbeGEX · Traditional | 11/03/1994SE |
| K944470 | Curved Endophotocoagulator Laser ProbeGEX · Traditional | 11/03/1994SE |
| K944632 | Model 120-SS Laser Delivery ProbeGEX · Traditional | 11/01/1994SE |
| K944631 | Model 120-SC Laser Delivery ProbeGEX · Traditional | 11/01/1994SE |
Questions and answers
When was ORS-100 cleared by the FDA?
ORS-100 (K921568) received a 510(k) decision of Substantially Equivalent on June 9, 1992, 68 days after the submission was received.
What is the product code of K921568?
The FDA product code is JRM – Freezer, a Class I (low risk) device regulated under 21 CFR 862.2050.