Opportunity Inc. Bone Marrow Biopsy and Aspiration Tray
FDA 510(k) K971061 · Opportunity, Inc.
510(k) numberK971061
Submission
- Device name
- Opportunity Inc. Bone Marrow Biopsy and Aspiration Tray
- Applicant
- Opportunity, Inc.
Highland Park, IL, US - Received
- March 24, 1997
- Decision date
- June 11, 1997
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- LRO – General Surgery Tray
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Other 510(k)s with product code LRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213481 | Medline General Surgery TrayLRO · Traditional | Medline Industries, Inc. | 05/24/2022SE |
| K212258 | Medline Cardiovascular Procedure KitLRO · Traditional | Medline Industries, Inc. | 12/03/2021SE |
| K041080 | Surgical Drape Kit - D.I.R.R.A. SRLLRO · Traditional | D.I.R.R.A. S.R.L. | 11/30/2004SE |
| K030721 | Quick-Tap Paracentesis Tray, Kit & NeedleLRO · Special | Ballard Medical Products | 03/31/2003SE |
| K023276 | Amsino Tracheostomy Care TrayLRO · Traditional | Amsino International, Inc. | 12/09/2002SE |
| K980137 | Worldwide Medical Technologies Bone Marrow Biopsy Procedure TrayLRO · Traditional | Worldwide Medical Technologies, LLC | 01/30/1998SE |
| K971062 | Opportunity Inc. General Purpose TrayLRO · Traditional | Opportunity, Inc. | 06/09/1997SN |
| K932221 | Neurological or Crani Trays (Packs)LRO · Traditional | Associated Medical Products Co. | 03/19/1997SE |
| K970286 | Presbyterian Linen Services Surgical PacksLRO · Traditional | Medline Industries, Inc. | 03/10/1997SE |
| K970187 | Runyon Large Volume Paracentesis KitLRO · Traditional | Gi Supply | 02/14/1997SE |
More from Gi Supply
| 510(k) | Device | Decision |
|---|---|---|
| K971095 | Opportunity Suture Removal KitEFQ · Traditional | 09/16/1997SN |
| K971093 | Opportunity I.V. Start KitMGP · Traditional | 09/16/1997SN |
| K971091 | Oppurtunity Tracheostomy Care KitKMF · Traditional | 09/16/1997SN |
| K971090 | Opportunity Dressing Change TrayKMF · Traditional | 09/16/1997SN |
| K971089 | Opportunity, Inc. Laceration TrayKKX · Traditional | 09/16/1997SN |
| K971088 | Opportunity Incision and Drainage TrayEFQ · Traditional | 09/16/1997SN |
| K971062 | Opportunity Inc. General Purpose TrayLRO · Traditional | 06/09/1997SN |
Questions and answers
When was Opportunity Inc. Bone Marrow Biopsy and Aspiration Tray cleared by the FDA?
Opportunity Inc. Bone Marrow Biopsy and Aspiration Tray (K971061) received a 510(k) decision of Substantially Equivalent for Some Indications on June 11, 1997, 79 days after the submission was received.
What is the product code of K971061?
The FDA product code is LRO – General Surgery Tray, a Class II (moderate risk) device regulated under 21 CFR 878.4370.