510(k) · Cleared
Recalled · 2011Mani Needle & Suture Pack (Pga Absorbable)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mani, Inc. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Mar 14, 2006 as substantially equivalent to K984374 (Samyang Corp., 1999) after a 75-day review. Its family tree reaches back 1 generation to 1999. It has been recalled 6 times.
- Decided
- Mar 14, 2006
- Review
- 75 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984374 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK984374 SurgisorbSamyang Corp. · 1999
- This deviceK053636 Mani Needle & Suture Pack (Pga Absorbable)Mani, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984374 | Surgisorb | Samyang Corp. | 1999 | — |
| 0 (this device) | K053636 | Mani Needle & Suture Pack (Pga Absorbable) | Mani, Inc. | 2006 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K984374 | SurgisorbSummary page 1…bable (21 C.F.R. § 878. 878.4493) Product Code: GAM Predicate Devices: Surgisorb Absorbable PGA Sutures, 510(k) # 984374. Device Description: The MANI Needle & Suture Pack (PGA Absorbable) consists of a stainless steel… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2011 | Not classified | Z-0650-2012 | Component change control | Surgical sutures may be weak and may not function as intended during surgical procedures. |
| Jul 20, 2011 | Not classified | Z-0654-2012 | Component change control | Surgical sutures may be weak and may not function as intended during surgical procedures. |
| Jul 20, 2011 | Not classified | Z-0649-2012 | Component change control | Surgical sutures may be weak and may not function as intended during surgical procedures. |
| Jul 20, 2011 | Not classified | Z-0651-2012 | Component change control | Surgical sutures may be weak and may not function as intended during surgical procedures. |
| Jul 20, 2011 | Not classified | Z-0652-2012 | Component change control | Surgical sutures may be weak and may not function as intended during surgical procedures. |
| Jul 20, 2011 | Not classified | Z-0653-2012 | Component change control | Surgical sutures may be weak and may not function as intended during surgical procedures. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 6 other devices also cite its predicate K984374.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
The MANI Needle & Suture Pack (PGA Absorbable) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053636: Mani Needle & Suture Pack (Pga Absorbable).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053636
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026